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Alkylating agents

Melphalan/HDS for Intrahepatic Cholangiocarcinoma

Phase 2 & 3
Waitlist Available
Research Sponsored by Delcath Systems Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up orr change will be assessed every 9 weeks through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial will compare two groups of patients with intrahepatic cholangiocarcinoma, one of which will receive high-dose chemotherapy delivered specifically to the liver. The other group will continue with the standard cisplatin and gemcitabine treatment. The results will be measured in terms of overall survival.

Eligible Conditions
  • Intrahepatic Cholangiocarcinoma
  • Cholangiocarcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pfs change will be assessed every 9 weeks through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and pfs change will be assessed every 9 weeks through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival
Secondary outcome measures
Objective response rate (CR + PR) as determined by the Investigator
Progression-free survival, as determined by IRC
Other outcome measures
Incidence of Treatment-Emergent Adverse Events (Safety)
Objective response rate as determined by IRC
Pharmacokinetic Outcome Measures: AUC
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Melphalan/PHPExperimental Treatment1 Intervention
Patients may receive up to 6 treatments of Melphalan/HDS 3.0 mg/kg IBW. Each treatment cycle consists of 6 weeks with an acceptable delay for an additional 2 weeks (i.e. 8 weeks in total). The maximum dose of melphalan will be 220 mg per treatment.
Group II: Cisplatin and GemcitabineActive Control1 Intervention
Each Cis/Gem treatment cycle will comprise cisplatin, dosed at 25 mg per square meter of body surface area, and gemcitabine, dosed at 1000 mg per square meter of body surface area. Each will be administered on Days 1 and 8 every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melphalan/HDS
2016
Completed Phase 3
~110

Find a Location

Who is running the clinical trial?

Delcath Systems Inc.Lead Sponsor
8 Previous Clinical Trials
498 Total Patients Enrolled
1 Trials studying Intrahepatic Cholangiocarcinoma
17 Patients Enrolled for Intrahepatic Cholangiocarcinoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are in this control group?

"This study is no longer recruiting participants. The trial's first posting was on 4/10/2018, with the most recent edit on 3/23/2022. There are currently 1112 trials for Melphalan/HDS and 224 for bile duct cancer that are looking for patients."

Answered by AI

Can people with the required medical conditions enroll in this study right now?

"Unfortunately, this clinical trial is no longer recruiting patients, as stated on clinicaltrials.gov. The trial was initially posted on April 10th, 2018 but was last updated on March 23rd, 2022. Although this specific study is not looking for participants, there are 1,336 other trials that are."

Answered by AI

What other scientific research has been completed on Melphalan/HDS?

"There are 1112 studies currently being conducted on Melphalan/HDS. Of those, 359 are clinical trials in Phase 3. Most of the studies for Melphalan/HDS are based in Shanghai, but there are 53507 locations running studies for this treatment."

Answered by AI

What are the most common conditions that Melphalan/HDS is effective in treating?

"Melphalan/HDS is commonly used to treat neoplasm metastasis. It can also be used to treat conditions including urinary bladder, advanced testicular cancer, and small cell lung cancer (sclc)."

Answered by AI
~43 spots leftby Mar 2025